Cleared Abbreviated

ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) (K103643) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K103643 · Ascot Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
297d
Days
Class 2
Risk

K103643 is an FDA 510(k) clearance for the ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS). Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Ascot Technologies, Inc. (Cary, US). The FDA issued a Cleared decision on October 6, 2011 after a review of 297 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ascot Technologies, Inc. devices

Submission Details

510(k) Number K103643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2010
Decision Date October 06, 2011
Days to Decision 297 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 125d · This submission: 297d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

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